SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma

NCT00991250 | Unknown Phase 2 DMC

• 2 other identifiers: Mel-Swe-01 2009-12-17EudraCT No: 2008-007515-33
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to elucidate whether SentoClone® gives improved treatment responses in patients with advanced malignant melanoma in comparison to established reference treatment(s).

Conditions

Malignant Melanoma

Keywords

Malignant melanoma

Outcome Measures

Primary Outcomes (1)

• Tumour response rate, defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.

  At baseline and 18, 26 and 34 weeks after treatment

Secondary Outcomes (10)

• Progression-free survival

  From baseline to week 34 after initiated treatment

• Overall survival

  From baseline to week 34 after initiated treatment

• Time to tumour progression

  From baseline to week 34 after initiated treatment

• Disease-free survival

  From baseline to week 34 after initiated treatment

• Time to treatment failure

  From baseline to week 34 after initiated treatment

Study Arms (2)

SentoClone®

EXPERIMENTAL

SentoClone®: Specific tumour-reactive lymphocytes located in lymph nodes directly draining primary tumours or metastases are identified and expanded. These lymphocytes are infused to the patient to treat metastatic disease.

Biological: SentoClone®

Temodal® or Dacarbazine Medac®

ACTIVE COMPARATOR

To be decided by each centre as one of the following: 1. Temodal® (temozolomide) 2. Dacarbazine Medac® (dacarbazine) The reference treatment regimen should follow the general guiding principles for each of the two reference treatments.

Drug: Temodal® or Dacarbazine Medac®

Interventions

SentoClone® BIOLOGICAL

SentoClone® are autologous tumour-reactive lymphocytes which are expanded and infused to the patient, where they have the opportunity to seek out and attack the primary tumour and metastases. The first step is to identify the tumour draining lymph node(s), which is done in parallel to surgical resection of the primary tumour or metastasis. The sentinel and/or metinel node(s), the initial meeting place between tumour antigen and the immune system, are further dissected and collected during the surgery. The lymphocytes are extracted from the collected lymph nodes and expanded in vitro, the lymphocytes are thereafter stimulated with tumour extract and returned to the patient intravenously as an autologous cell transfusion. The administered volume will be 100 ml for cell densities less than 3x106 cells/ml and 200 ml for cell densities of 3x106 cells/ml or more.

SentoClone®

Temodal® or Dacarbazine Medac® DRUG

Dacarbazine (5-\[3,3-Dimethyl-1-triazenyl\]imidazole-4-carboxamide) is a widely used systemic treatment against advanced malignant melanoma. Dacarbazine is a cytostatic agent, which inhibits tumour growth by interfering with DNA-synthesises. The DNA-synthesis is inhibited by alkylation of the DNA molecule; however, it is unclear whether dacarbazine has other cytostatic impacts on cell mechanisms. Dacarbazine is inactive until liver passage, the liver converts dacarbazine to its reactive metabolites MTIC and HMMTIC, which alkylate DNA. Dacarbazine is light sensitive and needs to be administered intravenously. A newer analogue to dacarbazine, temozolomide (Temodal®), has been developed for oral administration. Temodal® is administered in capsules and is rapidly absorbed reaching peak concentrations after 20 minutes. Temodal® is converted to MTIC at physiological pH, the same reactive molecule as dacarbazine is metabolized to in the liver.

Also known as: DTIC, Dacarbazine, Temozolomide

Temodal® or Dacarbazine Medac®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically incurable stage III or IV malignant melanoma
• At least one measurable lesion
• WHO performance status 0-1
• Life expectancy \> 3 months
• Diagnosed metastasis
• One tumour draining lymph node surgically accessible
• Measurable tumour manifestation after the harvest of tumour tissue and sentinel/metinel nodes(1)
• Signed informed consent
• (1) Should be fulfilled after surgery (visit 2) for patients randomised to SentoClone®.

You may not qualify if:

• \. Known allergy against used trace substance patent blue and/or albumin technetium (Nanocoll) 2. Known allergy against gentamicin and/or phenol red 3. Any condition (medical, social, psychological or legal) that influences adequate information negatively or is considered to be a problem for the patient to cope with treatment and follow-up 4. Aplastic anaemia or myelofibrosis 5. Previous treatment with temozolomide or dacarbazine, or any other chemotherapy during the last 3 months 6. Disease progression following treatment with temozolomide or dacarbazine more than 3 months back(1) 7. Previous radiotherapy of target lesion(s) or tumour draining lymph nodes which will be used for lymphocyte extraction(2) 8. Ongoing systemic steroid treatment or other treatment influencing immune defence 9. History of other malignant tumour disease apart from adequately treated basalioma or squamous cell carcinoma of the skin more than 5 years ago 10. Positive test(s) for HIV and/or Hepatitis B and/or Hepatitis C and/or syphilis 11. Condition or disease which could influence the result of the study or which indicates that the patient runs risks by participating in this study 12. Participation in any other clinical study, involving other investigational methods or products that may influence the results of this trial, within 30 days prior to participating in this trial
• Irradiated lesions are not considered to be measurable and are therefore not suitable as target lesions. Lesions which have been irradiated but shown progression are considered as measurable.

Sponsors & Collaborators

• SentoClone AB: lead

Study Sites (5)

Lunds Universitetssjukhus

Lund, Skåne County, 22185, Sweden

RECRUITING

Södersjukhuset

Stockholm, Stockholm County, 11883, Sweden

RECRUITING

Karolinska Sjukhuset

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

Norrlands Universitetssjukhus

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, 41685, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian Ingvar, MD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

SE (5)